Having the appropriate Quality Management System in place and complying with Good Manufacturing Practices (GMP) or with ISO 13485 requirements is mandatory for healthcare companies, mainly  pharmaceutical companies and medical device companies before getting their products approved by health authorities. Additionally, pharmaceutical and medical device companies must maintain the same quality management system during the whole lifecycle of their products.

Barrco Regulatory Solutions Quality team has the required skills, experience and certifications to assist healthcare companies develop the required quality standard operating procedures (SOPs), implement and maintain the appropriate quality management system to be in compliance with GMP or ISO13485 requirements through the whole product’s cycle. Our quality auditors can help you prepare for FDA or other inspections and responses.

Remote Quality Audit (e-Audit) services
A remote quality audit, also known as a QA e-audit, is exactly the same as a site quality audit, the only difference is that is uses technology to communicate remotely with the auditee and also to evaluate data remotely to determine the extent of conformity of the auditee to the audit criteria and applicable quality standards.

Audit preparation services:
Our quality team has the skills and expertise to prepare a company for the below audits –
GLP audit, ISO audit, GMP audit, cGTP audit, GCP audit, GAP Analysis audit, Country specific audit (for Russia, Nigeria, Cambodia, Kazakhstan, Uzbekistan ect), FMA audit, PICS audit, ROW audit, EuGMP audit, UKMHR audit, USFDA audit.

Audit planning
The audit plan should clearly identify what, when and how the audit will be conducted.

Audit planning should include the following activities:
– assess and document feasibility and risks of e-audit with the auditee;
– determine the different technologies to be used during the e-audit and how they will be used;
– define the agenda that may need to accommodate the disposition of different team members at the audit site;
– make best use of time, more detailed definition of themes to be handled in different timeslots
which will require a better and previous understanding of the processes of the organization, etc.);
– identify the people to be audited and ensure their availability at defined time;
– test the technology before the audit to confirm that there is a stable connection and people know how to use it

QA SOP development services
Quality Standard Operating Procedures (QA SOPs) are written documents that provide instructions how to perform quality activities within an organization. The development, implementation, and maintenance of the appropriate QA SOPs are crucial for a successful quality management system.
To demonstrate the quality of the products to health authorities, a company must have an appropriate QA SOP and follow the same. Without an appropriate QA SOP, a company or individuals will not have the appropriate information and instructions how to perform properly their tasks and assume their responsibilities.

Our quality team has the skills and expertise to develop, implement and maintain the appropriate a tailored QA SOP for your quality management system and organization.